ASTM D4775 D4775M-2009 Standard Specification for Identification and Configuration of Prefilled Syringes and Delivery Systems for Drugs (Excluding Pharmacy Bulk Packages)《药物(不包括大批量.pdf

1、Designation: D 4775/D 4775M 09Standard Specification forIdentification and Configuration of Prefilled Syringes andDelivery Systems for Drugs (Excluding Pharmacy BulkPackages)1This standard is issued under the fixed designation D 4775/D 4775M; the number immediately following the designation indicate

2、s theyear of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of lastreapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers the identification o

3、f:1.1.1 The drug contained in the prefilled syringe or deliverysystem.1.1.2 The concentration, volume, and total amount of thedrug, and whether it is to be diluted prior to administration.1.2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The value

4、s stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combiningvalues from the two systems may result in non-conformancewith the standard.NOTE 1The values in SI units are the recommended values.2. Referenced Documents2.1 ASTM Standards:2

5、D 996 Terminology of Packaging and Distribution Environ-mentsD 4267 Specification for Labels for Small-Volume (100 mLor Less) Parenteral Drug ContainersD 7298 Test Method for Measurement of Comparative Leg-ibility by Means of Polarizing Filter Instrumentation3. Terminology3.1 General definitions for

6、 packaging and distribution envi-ronments are found in Terminology D 996.3.2 Definitions of Terms Specific to This Standard:3.2.1 delivery systemas used in this specification,aclosed system consisting of a container of concentrated solu-tion or powder which facilitates the transfer of the contents i

7、ntoa diluent prior to administration or use.3.2.2 pharmacy bulk packagedrug supplied in a stockcontainer to be held in the pharmacy and used for multipledispensing.3.2.3 syringean instrument by means of which drugs insolution or other liquids are injected into or withdrawn fromany vessel or cavity.4

8、. Significance and Use4.1 Difficulties have occurred in the correct identification ofsyringes containing significantly different medications oncethey have been removed from their cartons. The objective ofthis specification is to facilitate identification of the drug, itsconcentration, volume, and to

9、tal amount.4.2 Difficulties have also occurred in distinguishing be-tween syringes containing drugs ready for intravenous injec-tion and similar syringes containing solutions which must bediluted before use. An objective of this specification is tominimize the chance for such errors.5. Label Require

10、ments5.1 Label copy shall comply with Specification D 4267 andshall include the information required by regulation and by themanufacturer. In addition, the requirements of the followingsections shall apply.5.2 In syringes of the type shown in Fig. 1, 10-point orlarger type is preferred for the drug

11、name and the amount ofdrug per millilitre, or total amount as appropriate. This typeshall satisfy the test for legibility in 7.1, but at a distance of 500mm 19.7 in. This information shall be legible with minimalrotation of the immediate drug container.5.3 In syringes of the type in Fig. 2, where th

12、e immediatedrug container is fitted into the syringe barrel, the drug name,concentration, and total volume shall appear as close to theextreme right hand end of the drug containerthat is, theopposite end to the needleas possible, in bold type, in heightat least equal to one ninth of the external cir

13、cumference of thecontainer up to a maximum of 10 mm.5.3.1 The opaque background of these two lines of text shallnot exceed one third of the circumference of the container.There shall be good contrast between the type used for the drugname, concentration, and total volume, and either the drug1This sp

14、ecification is under the jurisdiction of ASTM Committee D10 onPackaging and is the direct responsibility of Subcommittee D10.32 on Consumer,Pharmaceutical and Medical Packaging.Current edition approved Oct. 1, 2009. Published October 2009. Originallyapproved in 1988. Last previous edition approved i

15、n 2004 as D 4775 04.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume information, refer to the standards Document Summary page onthe ASTM website.1Copyright ASTM International, 100 Barr H

16、arbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.container or an added opaque label background sufficient toconform with Section 7. The name of the drug on the containershall be legible through the barrel during preparation and usesufficient to conform with Section 7.5.4 Dis

17、tinctive labels or other means of distinguishingsyringes and containers filled with medications which can onlybe given safely by specific routes (such as anti-cancer drugs)shall be employed.5.5 Syringes and containers of medications intended onlyfor regional anesthesia shall be clearly marked as suc

18、h.6. Delivery Systems6.1 Delivery systems, for drugs which must be dilutedbefore administration, shall not resemble a normal syringe andshall be unsuitable for direct intravenous line injection (seeFig. 3). Such drugs shall preferably be supplied as a powder ina delivery system designed to facilitat

19、e the addition of thepowder to the container of parenteral solution. If supplied as aconcentrated solution, the immediate container shall not allowthe use of a standard syringe to transfer the concentratedsolution to a container of parenteral solution.6.2 The drug container shall be labelled “Dilute

20、 BeforeUse” or other appropriate warning, in at least 10-point boldtype in dark ink, whenever space permits, preferably within ared fluorescent box, such as Pantone 805 (see Fig. 3).6.3 When copy space is not sufficient for 10-point type size,the warning shall be at least equal in size to the name a

21、ndstrength designations of the drug. In addition to the label on thecontainer, “Dilute Before Use” or other appropriate warningshall be prominently displayed on the box and in accompany-ing instructions.7. Legibility Test7.1 Copy legibility of the proprietary name or establishedname of the drug and

22、the amount of drug per unit and totalvolume shall be evaluated using the preferred method fordetermining legibility as specified by Test Method D 7298.7.2 The alternative test for copy legibility of the proprietaryname or established name of the drug and the amount of drugper unit and total volume m

23、ay be determined using theLegibility Test outlined in Specification D 4267 whereby thecopy for the proprietary name or established name of the drugand the amount of drug per unit and total volume shall belegible in a light of 215 lx 20 fc at a distance of 155 cm 5 ft(see 5.3) by a person with 20:20

24、unaided or corrected vision.8. Keywords8.1 delivery systems; label requirements; legibility; prefilledsyringesASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advised

25、 that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either rea

26、pproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If yo

27、u feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual

28、 reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).FIG. 1 Label on Syringe Type ShownFIG. 2 Label on Syringe Type ShownFIG. 3 Label on Delivery System with SpikeD 4775/D 4775M 092